Nihon Kohden America Inc: Medical Device Recall in 2024 - (Recall #: Z-0268-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each

Product Classification:

Class II

Date Initiated: September 18, 2024

Date Posted: November 6, 2024

Recall Number: Z-0268-2025

Event ID: 95426

Reason for Recall:

Due to oximeters not having FDA market approval or clearance to distribute in the U.S.

Status: Ongoing

Product Quantity: 64

Code Information:

Model num.: 809030007 UDI-DI: 06970758500159 All lot numbers

Distribution Pattern:

U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT, NC, ND, NE, NH, OK, PA, SC, TX, VT, WA, and WI. O.U.S.: N/A

Voluntary or Mandated:

Voluntary: Firm initiated